Clinical Course of Functional Dyspepsia and Factors Predicting Outcome in Patients Receiving Medication-based Treatment

NCT05513040 | Recruiting DMC

• 1 other identifier: KY20222180-F-3
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 4

Brief Summary

Functional dyspepsia (FD) is one of most common chronic gastrointestinal disorders. Several types of drugs were demonstrated to be effective in reduction or remission of symptoms and severity of FD, including proton pump inhibitors (PPI), Tricyclic antidepressant and prokinetics. However, the clinical course of FD after taking medication-based treatment was unknown. Furthermore, 20-50% patients remained persistent or worsening of dyspepsia symptoms after treatment. Previous studies have suggested psychological factors (eg. anxiety, sleep disturbance) were related to less improvement of symptoms in natural clinical course. However, there is limited evidence in terms of clinical and psychological factors for less improvement in patients receiving medication treatment for dyspepsia.

Conditions

Functional Dyspepsia

Outcome Measures

Primary Outcomes (1)

• score of 4 (slightly better) or 5 (much better) on a 5-point Likert scale assessing symptom improvement at 6 months after the initial visit

  A 5-point likert scale was used for accessing symptom relief. 1. Worse, 2,slightly worse, 3.same, 4.slightly better, 5.much better. A score of 4 or 5 was classified as relief response.

  6 months

Secondary Outcomes (7)

• subtypes of functional dyspepsia

  6 months

• Short Form of Nepean Dyspepsia Index (SF-NDI)

  1 day

• Hospital anxiety and depression scale

  1 day

• Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionaire.

  1 day

• the change of Global Overall Symptom score (GOSS)

  1month, 3 months, 6 months,12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged ≥ 18 years old who met criteria of functional dyspepsia defined by Rome IV were eligible for our study.

You may qualify if:

• age ≥18 years old
• Patients who met Rome IV criteria
• Normal upper endoscopy and abdominal ultrasonography within one year

You may not qualify if:

• Patients with local or systemic diseases which may cause dyspeptic symptoms:
• Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.; Known acute or chronic injury of liver or kidney; Obvious hematological abnormality, or endocrine and metabolic diseases; Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.; Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)
• organ failure defined by Marshall standard
• severe psychiatric illnesses
• known malignancy
• pregnancy or lactation
• unable to provide consent
• suspected or identified bowel obstruction

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (4)

Lanzhou University Second Hospital

Lanzhou, Gansu, China

NOT YET RECRUITING

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Xijing 986 Hospita

Xi'an, Shaanxi, 710032, China

NOT YET RECRUITING

Xijing Hospital of Digestive Diseases

Xi'an, Shaanxi, 710032, China

RECRUITING

Central Study Contacts

Yanglin Pan

CONTACT

13991811225; yanglinpan@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 23, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: June 1, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Locations

CN (4)